The prostate gland (or prostate) is a walnut-sized, mucous-producing organ in males that lies just below the urinary bladder. The prostate typically grows starting at puberty until about the age of 30, when equilibrium is established between cell growth and apoptosis. Hormonal changes later in life, when coupled with diets that do not provide adequate nutrition for the prostate cells and hormonal system, may retrigger growth, leading to benign prostatic hypertrophy, or abnormal enlargement of the prostate. The only known function of the prostate is to produce a secretion that nourishes and protects sperm during reproduction. The urethra passes through the prostate gland. Hypertrophy or hyperplasia of the prostate may affect the function of the urethra, usually by occlusion of the urethra.
In men, the prostate gland is the source of several common disorders including prostatitis and benign prostatic hypertrophy (“BPH”), wherein the prostate gland becomes inflamed or enlarged. Prostatitis is defined as an inflammation or infection of the prostate gland. While prostatitis may be acute, associated with systemic findings of fever, chills and rigors, most cases of prostatitis are chronic and tend to be incurable with relatively frequent recurrences despite optimal standard medical therapy. Chronic prostatitis (inflammation or infection of the prostate) is common to all adult men. It is associated with virtually all cases of prostate cancer and is present in every prostate biopsy regardless of other findings.
In the early phase of prostatic enlargement, the bladder muscle has to force urine through the narrowed urethra by contracting more forcefully. Over a period of time, this forcing causes the bladder muscle to become stronger, thicker, and overly sensitive. In some cases, as prostate enlargement progresses and the urethra is squeezed more tightly, the bladder cannot overcome the problems created by the narrowed urethra. If this occurs, the bladder cannot empty completely. This situation creates a need to urinate more frequently. In a small percentage of men, incomplete emptying of the bladder may lead to repeated urinary tract infections, sudden inability to urinate, or gradual bladder and/or kidney damage. An enlarged prostate may even result in total blockage of the urethra, which a very serious condition.
Prostatitis encompasses any form of inflammation of prostate tissue. Only a relatively small percent is caused by bacterial infection, and increasing evidence suggests a link to sex steroid hormones. However, any chronic inflammation of the prostate is now suspected to be a risk factor for prostate cancer. Elevated levels of the inflammatory cytokine IL-8 promotes stromal and epithelail cell proliferation and is up-regulated in both BPH and aiPCa. IL-8 is also implicated in angiogenesis. This suggests a potentially causative link between prostatitis and PCa, and, while there is no causative association between BPH and PCa, a possible underlying mechanism common to both BPH and aiPCa. Vitamin D has been shown to be able to suppress the production of IL-8. These studies, therefore, support the proposition that treatments to reduce BPH and prostatitis, and the inclusion of dietary agents that potentate the effects of vitamin D3 on IL-8, will also reduce the incidence and progression of prostate cancer.
Prostate cancer is the third most common cause of death from cancer in men of all ages and is the most common cause of death from cancer in men over 75 years old. Prostate cancer is rarely found in men younger than 40. Men at higher risk include black men older than 60, farmers, tire workers, painters, and men exposed to cadmium. The lowest incidence occurs in Greece and several other areas of the Mediterranean, with rates among Japanese men about halfway between Greek men and men consuming a typical western diet. While diets in low incidence areas are high in vegetables and some fruits, vegetarian diets alone do not reduce incidence or mortality, as shown in a study of mortality rates for British vegetarians. Nutritional content of locally grown produce and fruits, herbs, and other components of the diets are more significant than gross meal composition. The cause of prostate cancer is unknown, although studies have shown a relationship to overall diet and lifestyle (i.e. Greek vs. Western Diets), obesity, metabolic syndrome, and hormone imbalances.
Prostate cancer is a serious and often life-threatening condition. It is characterized by rapidly-proliferating cell growth and continues to be the subject of worldwide research efforts directed toward the identification of therapeutic agents are effective in the treatment thereof. Effective therapeutic agents prolong the survivability of the patient, inhibit the rapidly-proliferating cell growth associated with the disease, or effect a regression of the disease. Research in this area is primarily focused on identifying agents are therapeutically effective in humans and other mammals. Therapeutic effectiveness may be measured most quickly by assessing blood flow diminution in tumors that have demonstrable blood flow pretreatment. This test is most accurately performed by employing Doppler ultrasound flows (Cornud F, Am J Radiol 74:1161,2000).
Common therapies for prostate cancer include prostatectomy, radiation, cryotherapy, and/or chemotherapy. More recently, the University Hospital of Belgium conducted a study showing antioxidants retarded the growth of many malignant and premalignant tumors. For patients with metastatic diseases, androgen deprivation via chemical or surgical means remains the last treatment modality. With passing time, however, cancer often becomes refractory to hormone ablation, leaving patients with metastatic disease no other conventional treatment options. These patients often seek unconventional “alternative” and/or “complementary” treatments, most commonly herbal therapies (phytotherapies). Such use is dramatically rising in recent years both in the U.S. and in Europe. The number of patients undergoing treatment with alternative medicine in the U.S. increased from 34% in 1990 to 42% in 1997. This number is still rising and there are now more visits to alternative health practitioners than total visits to all primary care physicians combined.
Many of these therapies seek to correct deficiencies or imbalances that may be present in a subject. For example, research suggests that low Coenzyme Q10 (“Q10”) levels may be linked to various types of cancers. One study compared 27 women with normal Pap smears with 75 women with cervical cancer and its precursor—cervical intraepithelial neoplasia. It was found that women with cervical cancer and neoplasia had lower concentrations of cervical/vaginal cell Q10 and vitamin E (alpha-tocopherol) compared to women with normal Pap smears. (Mikhail MS, et al. Coenzyme Q10 and a-tocopherol concentrations in cervical intraepithelial neoplasia and cervix cancer. Obstet Gynecol 2001;97).
In another study, 200 French women with malignant and non-malignant breast tumors were found to have reduced amounts of Q10 in their blood despite normal concentrations of vitamin E. (Jolliet P, et al. Plasma coenzyme Q10 concentrations in breast cancer: prognosis and therapeutic consequences. Fund Clin Pharmacol 1997;11).
In a still further study 21 Turkish women who underwent radical mastectomies for breast cancer found lower levels of Q10 within the breast tumor compared to the normal surrounding tissue. Four of the women had no detectable amounts of Q10 in the tumor or nearby tissue. (Portakal O, et al. Coenzyme Q10 concentrations and antioxidant status in tissues of breast cancer patients. Clin Biochem 2000;33:279-84).
Unfortunately, simply providing cancer patients with only supplements, such as Q10, is not sufficient in many cases because a supplement alone may lack cellular-bioavailability and/or function. Accordingly, formulations may need to address issues such as absorption, bioavailability, and activity in addition to supplementation of a deficiency.
TABLE 1 depicts an exemplary therapeutic composition that may be used to treat human male subjects for diseases or disorders or to promote cellular health, in accordance with one embodiment of the invention.
TABLE 2 depicts an exemplary composition that may be used to treat a female human subject for diseases including breast cancer, or any other cancer, and/or promote cellular health in accordance with one embodiment of the invention.